This retrospective real-world study evaluated safety outcomes in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) treated with subcutaneous IgPro20 (Immune Globulin [Human], 20% Liquid).

CIDP is a rare neurological disorder of the peripheral nervous system. Treatment recommendations include intravenous immunoglobulin (IVIg) as first-line treatment, and subcutaneous immunoglobulin for maintenance therapy.  

Adults with CIDP that initiated IgPro20 from 2015-2021 (date of initiation termed ‘index’) were identified by linked medical and pharmacy claims, hospital charge data, and electronic medical records. Eligible patients had a second CIDP diagnosis ≥90 days after initial diagnosis. Thirty safety outcomes, considered relevant from an immunoglobulin and/or infusion process perspective, were evaluated over a 6-month pre-index and available post-index up to 6 months (until discontinuation, switch, or end of follow-up). Patients were stratified into two cohorts based on prior use of IVIg. Within a cohort, event rate per person-month for each safety outcome was compared between the pre- and post-index using univariate Poisson generalized estimating equation models.

The final sample comprised 203 patients initiating IgPro20 (mean [SD] age 56.8 [16.4]; 57.6% female). The majority (n=121; 59.6%) had prior IVIg use, in which the event rate was statistically similar between the pre- and post-index periods for 26 of 30 safety outcomes (p≥0.05). A significant decrease in the event rate was observed for asthenia and hypertension (p<0.05). Patients without prior IVIg use (n=82), the event rate was statistically similar between pre- and post-index for 28 of 30 safety outcomes. For both cohorts, the event rate increased from pre- to post-index for abdominal/pelvic/neuropathic/back pain and a composite pain outcome (all p<0.0001), consistent with the known safety profile referenced in the current IgPro20 product label.

IgPro20 treatment in CIDP patients is associated with stable safety outcomes for patients switching from IVIg and those new to immunoglobulin therapy.